EU Manufacturer
๐บ๐ธ United States
Active
Philips Medical Systems
SRN: US-MF-000002321
ยท
Minuteman Road 3000, 01810 Andover, United States
Basic UDI-DIs
93
Total Devices
211
On Market
210
Off Market
1
Certificates
12
Valid
0
Expiring < 6mo
0
Countries
29
Basic Information
- Address
- Minuteman Road 3000, 01810 Andover, United States
- [email protected]
- Phone
- n/a
- Website
- n/a
Regulatory Overview
Regulation
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Eu Mdd
69
Eu Mdr
24
Classification
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Eu Md Class 2a
54
Eu Md Class 1
30
Eu Md Class 2b
9
Device Types
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Certificate Health
Total
12
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
11
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | EN ISO 13485:2016. | TรV SรD Product Service GmbH | Aug 24, 2020 | |||
| MDD Annex II (excluding section 4) | G1 044649 0046 | TรV SรD Product Service GmbH | Oct 01, 2020 | |||
| MDD Annex II (excluding section 4) | G1 044649 0046 Rev. 00 | TรV SรD Product Service GmbH | Mar 06, 2022 | |||
| MDD Annex II (excluding section 4) | G 1 044649 0046 Rev.00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 044649 0046 Rev .00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 044649 0046 rev. 00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 044649 0041 rev. 00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | Gl 044649 0046 Rev.00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G l 044649 0046 Rev .00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 044649 0046 Rev.00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 078838 0014 Rev.00 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CL 052098 0016 | TรV SรD Product Service GmbH | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 29 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 1-CHANNEL CHEMICAL THERMAL PAPER, GRAY | EU MDR | Eu Md Class 1 | On Market | 0 |
| 12L Leadset, Grabber, IEC | EU MDR | Eu Md Class 2a | On Market | 0 |
| 12L Leadset, Snaps, IEC | EU MDR | Eu Md Class 2a | On Market | 0 |
| 3 LEADS SET DISPOSABLE, BEDSIDE IEC RD | EU MDR | Eu Md Class 1 | On Market | 0 |
| 3 lead set, Disposable, Bedside, AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| 5 LEADS SET DISPOSABLE, BEDSIDE IEC RD | EU MDR | Eu Md Class 1 | On Market | 0 |
| 5 lead set Disp., Telemetry, AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| 5 lead set Disposable, Bedside, AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| 5-LEAD SET, DISPOSABLE, CHEST, AAMI | EU MDR | Eu Md Class 1 | On Market | 0 |
| 5-LEAD SET, DISPOSABLE, CHEST, IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| 6-LEAD SET, DISPOSABLE, BEDSIDE IEC | EU MDR | Eu Md Class 1 | On Market | 0 |
| 989803192931 | EU MDD | Eu Md Class 2a | On Market | 1 |
| ADULT FOAM ECG ELECTRODE, DISPOSABLE | EU MDR | Eu Md Class 1 | On Market | 0 |
| ADULT NIBP AIR HOSE 3.0M | EU MDR | Eu Md Class 1 | On Market | 0 |
| ADULT RADIOTRANSLUCENT FOAM ELECTRODE | EU MDR | Eu Md Class 1 | On Market | 0 |
| ATTACHMENT ELECTRODE | EU MDR | Eu Md Class 1 | On Market | 0 |
| AVALON CL BELT CLIP | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt Nsl CO2 Line LTerm | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt Nsl CO2 Line STerm | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt Nsl CO2 Line w/O2 LTerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Nsl CO2 Line w/O2 STerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Nsl CO2 Line w/O2 STerm Lng | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Orl/Nsl CO2 Line w/O2 Conn STerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Orl/Nsl CO2 Line w/O2 Conn STerm Lng | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Orl/Nsl CO2 Line w/O2 LTerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Orl/Nsl CO2 Line w/O2 LTerm Lng | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Orl/Nsl CO2 Line w/O2 STerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt Orl/Nsl CO2 Line w/O2 STerm Lng | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt/Med BiteBlk CO2 Line w/O2 Conn STerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt/Med BiteBlk CO2 Line w/O2 STerm | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt/Med BiteBlk CO2 Line w/O2 STerm Lng | EU MDD | Eu Md Class 2a | On Market | 1 |
| Adt/Pedi Intub CO2 Line High Humidity | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt/Pedi Intub CO2 Line LTerm | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt/Pedi Intub CO2 Line LTerm Lng | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt/Pedi Intub CO2 Line STerm | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adt/Pedi Intub CO2 Line STerm Lng | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adult NIBP Air Hose 1.5m | EU MDR | Eu Md Class 1 | On Market | 0 |
| Avalon CL Fetal & Maternal Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| BILECLIPSE, 50 PACK | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bilical, 50 Pack | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE | EU MDD | Eu Md Class 2b | On Market | 1 |
| CBL ECG 5 LEAD GRABBER IEC, SPU, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 5 LEAD GRABBER, IEC, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele | EU MDD | Eu Md Class 2b | On Market | 1 |
| CBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |
| CBL ECG 6 LEAD GRABBER, IEC, TELE | EU MDR | Eu Md Class 1 | On Market | 0 |